DEA Schedules Insys Therapeutics’ Syndros (dronabinol oral solution) as Schedule II Drug
23 March 2017 - 10:34PM
Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or the “Company")
today announced that the Drug Enforcement Agency (“DEA”) has issued
an interim final rule that would result in Syndros™ (dronabinol
oral solution) being placed in Schedule II of the Controlled
Substances Act.
On July 1, 2016, the Food and Drug Administration (“FDA”)
approved the New Drug Application for Syndros.
Dr. Santosh Vetticaden, Ph.D., M.D., Interim CEO, and Chief
Medical Officer, stated, “Insys is looking forward to bringing this
new drug product to chemotherapy patients to help alleviate their
nausea and vomiting and AIDS patients with anorexia associated
weight loss, respectively.”
“We look forward to interacting with the FDA to finalize the
labeling and subsequent launch of Syndros in the second half of
2017,” concluded Vetticaden.
Important Safety Information
Syndros is a cannabinoid indicated in adults for the treatment
of:
- Anorexia associated with weight loss in patients with AIDS,
and
- Nausea and vomiting associated with cancer chemotherapy in
patients who have failed to respond adequately to conventional
antiemetic treatments
The use of dronabinol may cause psychiatric and cognitive
effects and impair mental and/or physical abilities.Patients with
cardiac disorders may experience hypotension, hypertension, syncope
or tachycardia.May cause disulfiram-like reaction.Weigh the
potential risk versus benefits before prescribing Syndros to
patients with a history of seizures, including those requiring
anti-epileptic medication or other factors that lower the seizure
threshold.Assess risk for abuse or misuse in patients with a
history of substance abuse or dependence, prior to prescribing
Syndros and monitor for the development of associated behaviors or
conditions.Consider dose reduction or discontinuation, if worsening
of symptoms while on treatment.The safety and effectiveness of
Syndros have not been established in pediatric patients.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that
develops and commercializes innovative drugs and novel drug
delivery systems of therapeutic molecules that improve the quality
of life of patients. Using proprietary sublingual spray technology
and capabilities to develop pharmaceutical cannabinoids, Insys is
developing a pipeline of products intending to address unmet
medical needs and the clinical shortcomings of existing commercial
products. Insys currently markets one product, SUBSYS® (fentanyl
sublingual spray) but has received approval for the marketing of
SYNDROS™ (dronabinol oral solution), a proprietary, orally
administered liquid formulation of dronabinol that Insys believes
has distinct advantages over the current formulation of dronabinol
in soft gel capsule. Insys is committed to developing medications
for potentially treating addiction to opioids, opioid overdose,
epilepsy, and other disease areas with high unmet need.
SUBSYS® and SYNDROS™ are trademarks of Insys Development
Company, Inc., a subsidiary of Insys Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding (i) the anticipated scheduling and
launch of SYNDROS™, (ii) the belief that the Company has the
potential to benefit patients in areas of unmet medical needs and
(iii) the belief that SYNDROS has distinct advantages over the
current formulation of dronabinol in soft gel capsule. These
forward-looking statements are based on management's expectations
and assumptions as of the date of this press release, and actual
results may differ materially from those in these forward-looking
statements as a result of various factors, many of which are beyond
our control. For a description of these risks facing the company,
please see the risk factors described in our filings with the
United States Securities and Exchange Commission, including those
factors discussed under the caption "Risk Factors" in our Annual
Report on Form 10-K for the year ended December 31, 2015 and any
subsequent updates that may occur in our Quarterly Reports on Form
10-Q. Forward-looking statements speak only as of the date of this
press release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
Contact:
Lisa M. Wilson
212-452-2793
E: INSYS@insysrx.com
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